Published: 21:18, July 25, 2023 | Updated: 21:23, July 25, 2023
HKBU's TCM drug gets FDA approval for clinical trial
By Atlas Shao

This photo taken from Hong Kong Baptist University's website shows the Shaw Tower located in the university's Shaw Campus.

A new traditional Chinese medicine drug developed by the Hong Kong Baptist University has obtained the approval of the Food and Drug Administration (FDA) of the United States for clinical trial, which is Hong Kong’s first TCM drug to receive the recognition.

The drug, which is used to treat constipation, was developed by the Centre for Chinese Herbal Medicine Drug Development (CDD) of the university. With the approval, the agency has been authorized to conduct a phase I clinical trial of the new drug in the US, which will be conducted later this year.

 "Chinese medicine compound has a good clinical effect in treating constipation, but it has not been recognized by the international market. The FDA approval, which symbolizes recognition by international counterparts, marked a big step forward for Chinese medicine in Hong Kong” said Bian Zhaoxiang, associate vice-president (Chinese Medicine Development) and director of the CDD at HKBU.

Alexander Wai Ping-kong, President and Vice-Chancellor of HKBU said that the clinical trial in the US will provide invaluable experience in conducting clinical trials at Hong Kong's first Chinese Medicine Hospital in the future

Briefing reporters about the research result on Tuesday, Bian said the FDA has a strict quality control system , and passing the test greatly boosted the research team’s confidence. He believes the clinical trial of this new drug will benefit patients in Hong Kong, the whole Guangdong-Hong Kong-Macao Greater Bay Area and even all over the world.

Bian added that chronic constipation is a common gastrointestinal disease, which affects a large number of people and is especially serious in the middle and old age people. At present, the clinical treatment of constipation is limited to changing dietary habits and drug intervention, and the effect is not ideal.

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While treating the disease, the TCM drug can also improve the patient's health. The patient can still experience sustained effects even stopped taking the medicine.

In recent years, Hong Kong government keeps increasing efforts to support the development of TCM in Hong Kong. In September 2020, Hong Kong Baptist University was funded by Innovation and Technology Commission (ITC) of the Hong Kong government to establish the CCD, which is the first comprehensive Chinese medicine research and development center among local universities in Hong Kong.

The center has six research teams,  separately focusing on clinical data science research, intestinal flora and metabolism research, immunity and intestinal inflammation research, Chinese medicine pharmacy research, Artificial Intelligence-driven drug development research and drug registration application.

Bian said, the center played an important role in this new drug development. Through the Center, they received professional advice and support from international experts and scientific committee experts, companies from the Chinese mainland, and the University of Macau. 

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He hopes to have a further cooperation on the research and development of Chinese medicine products with the mainland and overseas regions, and further promote the traditional wisdom of Chinese medicine to the world.

Alexander Wai Ping-kong, President and Vice-Chancellor of HKBU said that the clinical trial in the US will provide invaluable experience in conducting clinical trials at Hong Kong's first Chinese Medicine Hospital in the future.